Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Hepatitis C drugs, designed to decrease liver damage, have been scrutinized for escalating the problem. In the past, our articles have discussed the possible association between some specific hepatitis C drugs and liver cancer. Recently, the FDA has identified three hepatitis C drugs that may pose a threat to patients' liver function.
New Drug Warnings
On August 28, 2019, the FDA In Brief report, "FDA warns patients and health care professionals about rare instances of serious liver injury or failure with certain hepatitis C treatments in some patients with advanced liver disease" discusses the hepatitis C drugs Mavyret, Zepatier, and Vosevi, which have recently been found to cause worsening liver conditions. There have been 63 confirmed cases of patients taking these drugs and having this side effect.
The same day, Reuters published the article, "FDA flags serious risks with hepatitis C drugs from AbbVie, Gilead and Merck", identifying the manufacturers at the forefront of the situation and stating that they had not provided any comments on the issue.
According to the FDA, these hepatitis C drugs are approved for people with little to no liver damage but not for those with moderate to severe liver damage. The medicine will work safe and effectively on those with less damage.
Possible Rare but Severe Side Effects
The FDA In Brief article, brings to attention that when someone who already has moderate to severe liver damage takes these drugs, the result may be the worsening liver function called decompensation. This can lead to liver failure or even death.
The corresponding FDA Drug Safety Communication, "FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease", informs that patients who are at risk should look out for signs of worsening liver conditions which are: "fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools".
The FDA conveyed in the FDA In Brief article that,
In some cases, patients were reported as having no cirrhosis, or liver scarring, or cirrhosis with mild liver impairment (compensated cirrhosis) but had indications of advanced liver disease or risk factors for liver impairment, such as decreased platelets, portal hypertension (increased pressure in the portal vein, the vein that carries blood from the digestive organs to the liver) caused by a blockage in the blood flow through the liver, alcohol abuse or other serious medical illnesses associated with significant liver problems before starting treatment. In most patients, symptoms resolved or new onset worsening liver function improved after stopping the medicine.
The FDA notes that these three hepatitis C drugs are safe to continue prescribing to those as needed but if the patient is showing signs of worsening liver function, the drug should be stopped. Additionally, the risk should be known to the public but it is a rare occurrence and no one should stop the drug unless told by their doctor.
We will continue to provide any new or relevant information regarding the topic of hepatitis C drugs Mavyret, Zepatier, and Vosevi, and the risk of worsening liver conditions.
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